HurriCaine

Product NDC
0283-0522
11-digit product format
002830522
Labeler code
0283
Product ID
0283-0522_4cd3ac30-a3c5-8a91-e063-6294a90a61df
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL; ORAL; PERIODONTAL
Labeler
Beutlich Pharmaceuticals, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-31
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HurriCaine
Brand name suffix
Topical Anesthetic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910, 996288

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0522-27HurriCaineTopical Anesthetic42.52 g in 1 TUBEGEL42.523

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0522HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20250110_043c00a6-1346-7780-e063-6294a90a3d5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN043c00a6-1346-7780-e063-6294a90a3d5a3
996288HurriCaine 20 % Oral GelPSN043c00a6-1346-7780-e063-6294a90a3d5a3
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD043c00a6-1346-7780-e063-6294a90a3d5a3
238910benzocaine 0.2 MG/MG Oral GelSCD043c00a6-1346-7780-e063-6294a90a3d5a3
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY043c00a6-1346-7780-e063-6294a90a3d5a3
996288Hurricaine 0.2 MG/MG Oral GelSY043c00a6-1346-7780-e063-6294a90a3d5a3
996288Hurricaine 20 % Dental GelSY043c00a6-1346-7780-e063-6294a90a3d5a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0283-0522-270028305222742.52 g in 1 TUBE (0283-0522-27) 42.52 g2023-08-31NoNoCurrent